Many Americans are stuck waiting for access to new drugs that can cure hepatitis C.Related
FAST FACTSThe latest antiviral drugs can cure chronic hepatitis C for over 90 percent of patients.
Medicaid covers one millionpeople with hepatitis C, but sharply limits coverage of newer treatments.
Many doctors believe that everyone infected with the virus should be treated with the new drugs.
Exclusivity deals between pharmacy benefit managers (PBMs) and the makers of expensive new hepatitis C drugs have some observers hoping competition will begin to force down prices. But physicians and advocates for hepatitis C patients say these deals have done little to increase access to these curative drugs for the patients who need them.
“It's Maserati and Ferrari having a price war,” says Peter Bach, MD, the director of the Center for Health Policy and Outcomes at Memorial Sloan-Kettering Cancer Center in New York City, who has written extensively about drug pricing. List prices for the newest hepatitis C treatments start at $83,000 and go up from there, but are about 10 times as high they should be, Dr. Bach says. “These are still enormously expensive drugs, and a real price war would probably have a very different dynamic.”
Doctors and patient advocates feel most optimistic about a deal between ExpressScripts and drug manufacturer AbbVie to cover the hepatitis C medication Viekira Pak without limiting patients’ access to the drug — announced in December 2014. While the deal also included an undisclosed price discount for ExpressScripts, that isn't what matters to patients, says Camilla Graham, MD, the co-director of the Viral Hepatitis Center in the Division of Infectious Disease at Beth Israel Deaconess Medical Center in Boston.
“From my perspective, I don't care what the price is. What matters is that it's a price that allows the patients who I want to have access to that medicine to have treatment with that medicine,” Dr. Graham says.
“I get a little bit concerned when we have exclusivity deals and none of these price cuts that the payer is receiving from the pharmaceutical company translate to ease of access,” says Stacy Trooskin, MD, PhD, an assistant professor in the Division of Infectious Diseases and HIV Medicine at Drexel University College of Medicine in Philadelphia.
The latest deal, shortly followed by CVS's disclosure that it will only cover drug manufacturer Gilead's hepatitis C meds Harvoni and Sovaldi, is great news for the hepatitis C patients with private, employer-based insurance with pharmacy benefits managed by ExpressScripts. CVS has not disclosed whether it will also lift restrictions on access to the medications as part of its deal.
Access to New Drugs Limited for Medicaid PatientsNeither of these announcements will make it easier for patients on Medicaid — who account for one-third of the 3 million hepatitis C patients in the US — to get the new medications. They still face a crazy quilt of restrictions on access to the costly drugs, given that each state runs its own Medicaid program, and none have the budget to cover them at their list price.
- Some states will only cover the drugs for patients with the most severe liver scarring.
- Many also say patients must be prescribed the drugs by a liver specialist.
- Patients with substance abuse problems have to demonstrate sobriety to be covered.
Pennsylvania's Medicaid program, for example, restricts access to the new hepatitis C medications to patients with the most severe liver damage, and these patients must be sober. “Patients need to demonstrate that they have abstained from drugs and alcohol prior to the initiation of therapy,” says Dr. Trooskin. “Those two things together have made it very difficult to get the drug easily to all of our patients,” she added. “We've had other patients that have been denied drugs just because they have marijuana in their urine, and they're adherent to all of their other recommended medications.”
“We're finding that our poorest and disproportionately minority patients are being adversely affected by the restrictions that Medicaid has, and they're usually unwavering in those restrictions,” Trooskin says.
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Choice of Treatment vs. Rationing of Care“What it really comes down to is we're looking at a struggle between choice of treatment. Do we get to choose which treatment we want to use, or access to treatment, do we have the ability to treat anyone who comes to us with hepatitis C?” says Graham. “Normally we like to have a choice in both of those realms.” But when forced to pick one, Graham adds, “I would choose access to treatment, hands down every day.”
Every single Viekira Pak prescription Graham has written for her Medicaid patients has been denied, she says. “Things aren't going so well, and Massachusetts, I will say, has the best access of any state. Our Medicaid doesn't have ridiculous restrictions,” she added. “I'm calling them restrictions, but it's really rationing. We're seeing rationing of care for hepatitis C like I've never seen in U.S. medicine.”
Doctors say they are seeing rationing of hepatitis C care like never before.
At the heart of the issue is whether everyone with hepatitis C should receive curative treatment, given that most won't go on to develop severe liver damage, Bach says. About 10 percent to 15 percent of people withchronic hepatitis C infection will develop cirrhosis. But many doctors who treat patients with hepatitis C feel strongly that everyone with the virus who wants to be cured should get curative treatment. Right now, many simply cannot afford it. Find experts’ tips on how to pay for costly hepatitis C drugs here.
“It's going to take a very novel approach and a coming together of all parties to come up with a solution, to come up for treatment for everyone who needs it, which is everyone who's positive,” Trooskin says.